Home GUDID 34547410079358 FUJIFILM
Primary DI 34547410079358
Brand FUJIFILM
Company FUJIFILM CORPORATION
Model FOV-LL2
Device description This product is intended to prevent backflow of body fluid etc, from the forceps port of endoscope and to enable to insert treatment devices into the body cavity by attaching the forceps port of endoscope.
Published 2022-10-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name FFY Adaptor, bulbs, miscellaneous, for endoscope
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 34547410079358 Package GS1 1 In Commercial Distribution 04547410079357 Primary GS1 0 84547410079353 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 34547410079358 34547410079358 04547410079357 04547410079357 4547410079357 84547410079353 84547410079353
GMDN Terms# Term, Definition table Term Definition Endoscopic biopsy valve, single-use A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 There must be no condensation. Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Sterilization Methods# Method table Method Ethylene Oxide;High-level Disinfectant;Moist Heat or Steam Sterilization High-level Disinfectant;Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 713565195 Device count 10 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04547410480269 FUJIFILM VS-1000 2026-05-22 04547410529128 FUJIFILM EG-S100XT 2026-05-22 04573596200865 APERTO Lucent MR-JCR-82 Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22 04573596200889 APERTO Lucent MR-JC-81 Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et 2026-05-22 04573596200896 APERTO Lucent MR-JCR-83 Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22 04573596200902 APERTO Lucent MR-CSC-81 C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et 2026-05-22 04573596200940 APERTO Lucent MR-QWC-81 Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter 2026-05-22 04573596200964 APERTO Lucent MR-MSC-81 Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E 2026-05-22 04573596200971 APERTO Lucent MR-QRC-81 Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E 2026-05-22 04573596201480 APERTO Lucent MR-QHC-81R QD Head coil R MR-QHC-81R for APERTO Lucent 2026-05-22 04573596201497 APERTO Lucent MR-QKC-83R QD Knee coil R MR-QKC-83R for APERTO Lucent 2026-05-22 04573596201503 APERTO Lucent MR-IBC-83 Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22 04573596202210 APERTO Lucent MR-QFC-82N Flexible Body coil N(M) MR-QFC-82N for APERTO Luce 2026-05-22 04573596202227 APERTO Lucent MR-QFC-83N Flexible Body coil N(L) MR-QFC-83N for APERTO Luce 2026-05-22 04573596200704 APERTO Lucent APERTO Lucent APERTO Lucent 2024-09-19 04547410334494 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -B15- 2016-09-16 04547410334500 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -B20- 2016-09-16 04547410334517 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -B25- 2016-09-16 04547410334524 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -B30- 2016-09-16 04547410334531 Fujifilm Diathermic Slitter (FlushKnife) DK2618J -N10- 2016-09-16
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